Sparsentan

TOKYO, July 18, 2024 /PRNewswire/ -- Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; "Renalys Pharma") announced today that the first person was dosed in its registrational Phase III clinical trial of sparsentan for the treatment of IgA nephropathy in Japan. In April this year Renalys submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The registrational Phase III study is a multicenter, open-label, single arm study in Japanese patients with IgA nephropathy, and is planned to confirm the efficacy and safety of sparsentan in approximately 30 Japanese patients. Results from the urine protein/creatinine ratio (UP/C) endpoint in the study are expected in the second half of 2025 to support a submission for approval to PMDA. Sparsentan was developed by Travere Therapeutics, Inc. ("Travere"). Renalys Pharma has an exclusive license for development and commercialization of sparsentan in Japan, South Korea, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. In 2023, Travere received FDA accelerated approval for sparsentan (U.S. brand name: FILSPARI®) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression*. In addition, Travere submitted a supplemental New Drug Application to FDA in March 2024 which was granted as Priority Review and a PDUFA target action date of September 5, 2024, to convert the existing U.S. accelerated approval to full approval based on 2-year confirmatory results from the Phase III PROTECT Study, the only head-to-head study in IgA nephropathy versus an active comparator. In the PROTECT Study, FILSPARI® demonstrated a significant reduction in proteinuria, preservation of kidney function and a well-tolerated safety profile compared with active control irbesartan. Renalys Pharma is committed to advancing its business to contribute to improving the lives of patients in Japan and Asia through the development of innovative therapies that can improve the management of kidney disease, first and foremost by delivering sparsentan as soon as possible. *FILSPARI® (sparsentan) U.S. Indication: FILSPARI is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a UPCR ≥1.5 g/g. About IgA Nephropathy The management of patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD) has become a social issue that places a heavy burden on the Japanese healthcare system. IgA nephropathy is widely known as one of the main causes of kidney failure and is considered to develop when abnormal IgA proteins are deposited in kidney tissue, inhibiting kidney function and causing inflammation. IgA nephropathy is a rare intractable disease (designated as an intractable disease 66) with many unresolved mechanisms of onset and severity. Currently, there is a lack of treatment for IgA nephropathy and an unmet need for such treatment in Japan. About Renalys Pharma, Inc. Renalys Pharma, a privately held late-stage clinical biopharmaceutical company based in Japan, is committed to the development of multiple innovative therapeutics targeting unmet needs in the management of renal disease for Japanese and Asian patients. Founded by Catalys Pacific and SR One in 2023, the company aims to address the growing problem of "drug loss" by catalyzing access to new treatments for kidney disease patients in Japan and other Asian regions. Company Name: Renalys Pharma, Inc. Address: 3-11, Nihonbashi-honcho 2-chome, Chuo-ku, Tokyo, Japan Representative: BT Slingsby, MD, PhD, MPH Established: April 2023 URL: [Disclaimer] Information concerning pharmaceutical products (compound under development) contained herein is not intended as advertising or as medical advice, but intended for disclosure of management information. SOURCE Renalys Pharma, Inc.

Financing Round Co-led by Catalys Pacific and SR One, Investment to Drive the Development of Sparsentan for IgA Nephropathy in Japan and Other Asian Countries TOKYO, July 17, 2024 /PRNewswire/ -- Renalys Pharma, Inc., a late-stage clinical biopharmaceutical company has completed a ¥6.0Bn Series A financing. The financing was led by Catalys Pacific and SR One, along with additional investors, including JPS Growth Investment Limited Partnership, Sumitomo Mitsui Trust Bank Co., Ltd., Japan Co-Invest IV Limited Partnership, NVCC NO.9 Investment Limited Partnership. The Series A financing will enable Renalys Pharma to complete its Phase III clinical trial for sparsentan, a promising treatment for IgA nephropathy, in Japan. IgA nephropathy is a prevalent kidney disease in Japan and throughout Asia. Renalys Pharma obtained the rights to sparsentan through a licensing agreement with Travere Therapeutics, Inc. In April 2024, Renalys Pharma submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and plans to initiate an open-label registrational study in Q2 2024, with anticipated results from the urine protein/creatinine ratio endpoint in the second half of 2025. This Phase III registration study will bring Renalys Pharma closer to providing a much-needed treatment option for patients living with IgA nephropathy across the region. "Renalys is committed to developing innovative treatments that address growing healthcare inequities for patients in Japan and Asia," said BT Slingsby, founding CEO of Renalys Pharma and Founder and Managing Director of Catalys Pacific. "At Renalys, our paramount objective is to introduce new medicines that transform clinical medicine and patients' lives, beginning with sparsentan for IgA nephropathy." "SR One is proud to actively partner with entrepreneurs, offering our full support to build transformative biotechnology companies," said Rajeev Dadoo, PhD, Managing Partner of SR One. "We are thrilled to join forces with Renalys as they push forward their pipeline of what we believe to be innovative renal disease therapies. Our investment in Renalys reflects our confidence in their ability to develop much-needed new medicines for patients in Japan and across Asia." About Renalys Pharma, Inc. Renalys Pharma, a privately held late-stage clinical biopharmaceutical company based in Japan, is committed to the development of multiple innovative therapeutics targeting unmet needs in the management of renal disease for Japanese and Asian patients. Founded by Catalys Pacific and SR One in 2023, the company aims to address the growing problem of "drug loss" by catalyzing access to new treatments for kidney disease patients in Japan and other Asian regions. To learn more about Renalys Pharma, please visit . About Catalys Pacific Catalys Pacific is a transpacific life sciences investment firm that provides solutions for patients worldwide through the creation of investments in biopharma companies. Catalys Pacific is led by a team of entrepreneurs and investors who work closely with partners in academia, venture capital, and the pharmaceutical industry. The firm maintains offices in Japan and the West Coast of the US. For more information, visit catalyspacific.com. About SR One SR One is a transatlantic biotechnology investment firm that collaborates with entrepreneurs and investment partners in an effort to build elite biotechnology companies. SR One's mission is to translate innovative technologies and scientific discoveries into next-generation medicines with the potential to benefit patients with significant unmet medical needs. For more information, visit . Disclaimer Information concerning pharmaceutical products (compound under development) contained herein is not intended as advertising or medical advice but intended for disclosure of management information. SOURCE Renalys